Court Ruling Could Affect Genetic Patenting

Genetics

By Nadja Spiegelman

Published August 11, 2010, issue of August 20, 2010.
  • Print
  • Share Share

A federal court ruling striking down patents on two cancer-causing genes has the potential to shake up the world of genetic patenting.

Last year, the American Civil Liberties Union, together with 18 individual plaintiffs, brought a suit against Myriad Genetics, which holds the licenses to the patents on the BRCA1 and BRCA2 genes, which can cause breast and ovarian cancer. The genes in question carry mutations that dramatically increase the risk of breast, ovarian and prostate cancer, and are disproportionately common among Ashkenazi Jews.

In March of this year, U.S. District Court Judge Robert Sweet ruled that “isolating” a genetic sequence found in nature does not fundamentally change it, nor the information it holds, and therefore does not constitute a patentable product.

Myriad has appealed the decision, and many believe that it could prove to be a pivotal case that will shape the future of genetic patenting.

“I think this would be a landmark case for two reasons,” said Dr. Harry Ostrer, a plaintiff in the case. “One is that it’s specific and the other is that it’s generic. It’s specific to these genes, but it’s generic in that a ruling may apply to other genes as well. Then I think the whole notion of patenting natural products would be questioned.”

Opponents of genetic patents say that they stifle research and lead to artificially inflated test costs, limiting access to testing. Supporters of genetic patenting say that it gives incentives for research by allowing holders of patents to earn royalties from tests and research done by others on the gene.

“We sit in our research committees and say, ‘Do we have patent protection for this?’ ‘No?’ ‘Well, then we’re not going to do research and spend $40 million on it just to have another company create a knockoff product,’” Richard Marsh, executive vice president and general counsel at Myriad, told the Forward.

“We are the poster child that the patent system works,” Marsh said. “We spent over $2 million over the past 10 years to mature this product so that today a woman in middle America can walk into her doctor’s office and say, ‘You know, I have a family history of breast cancer,’ and he’ll say, ‘What insurance do you have?’ ‘Blue Cross.’ ‘That’s covered. We can get you the test.’ No other company would have spent the money and the time. You just don’t do that without the promise of patent exclusivity.”

A staff attorney with the ACLU, Chris Hansen, disputed the notion that the promise of a patent spurred the research in this area.

“We know for a fact that it’s not true in this instance,” Hansen said. “There were other labs looking for the gene who announced that they would not patent the genes or would patent it and make it available to everybody. The gene would have been found, and it would have been available.”

Lisbeth Ceriani, a plaintiff in the suit, is a 43-year-old woman who was diagnosed with cancer in both breasts. She claims that Myriad will not accept her insurance and that she is unable to get the tests to determine if she needs ovarian surgery.

“Myriad holds my fate and future in its administrative hands, unless of course I am able to pay $3,225 out-of-pocket. Unfortunately, as a result of my illness and treatment, I do not have an extra three grand right now,” she wrote in her plaintiff’s statement.

“There will always be a small percentage of people whose unique circumstance puts them outside the square box,” Marsh said. “There were five plaintiffs in the case [who claimed they were unable to receive testing due to costs], and I distinguish them against the 400,000 tests we’ve done. We appreciate that there are some people who can’t afford the test, and if you can’t afford the test, we’ll do it for free.”

But Ellen Matloff, director of genetic counseling at the Yale Cancer Center, pointed to the high cost of comprehensive BRCA1 and BRCA2 testing through Myriad.

“I’ve seen the cost of testing rise from $1,600 in the late 1990s to almost $4,000 today, even though the price of technology has gone so far down that the cost should have gone down as well,” said Matloff, who is also a plaintiff in the suit. “This test could easily be offered for less than $1,000.”


The Jewish Daily Forward welcomes reader comments in order to promote thoughtful discussion on issues of importance to the Jewish community. In the interest of maintaining a civil forum, The Jewish Daily Forwardrequires that all commenters be appropriately respectful toward our writers, other commenters and the subjects of the articles. Vigorous debate and reasoned critique are welcome; name-calling and personal invective are not. While we generally do not seek to edit or actively moderate comments, our spam filter prevents most links and certain key words from being posted and The Jewish Daily Forward reserves the right to remove comments for any reason.





Find us on Facebook!
  • Is pot kosher for Passover. The rabbis say no, especially for Ashkenazi Jews. And it doesn't matter if its the unofficial Pot Day of April 20.
  • A Ukrainian rabbi says he thinks the leaflets ordering Jews in restive Donetsk to 'register' were a hoax. But the disturbing story still won't die.
  • Some snacks to help you get through the second half of Passover.
  • You wouldn't think that a Soviet-Jewish immigrant would find much in common with Gabriel Garcia Marquez. But the famed novelist once helped one man find his first love. http://jd.fo/f3JiS
  • Can you relate?
  • The Forverts' "Bintel Brief" advice column ran for more than 65 years. Now it's getting a second life — as a cartoon.
  • Half of this Hillel's members believe Jesus was the Messiah.
  • Vinyl isn't just for hipsters and hippies. Israeli photographer Eilan Paz documents the most astonishing record collections from around the world:http://jd.fo/g3IyM
  • Could Spider-Man be Jewish? Andrew Garfield thinks so.
  • Most tasteless video ever? A new video shows Jesus Christ dying at Auschwitz.
  • "It’s the smell that hits me first — musty, almost sweet, emanating from the green felt that cradles each piece of silver cutlery in its own place." Only one week left to submit! Tell us the story of your family's Jewish heirloom.
  • Mazel tov to Chelsea Clinton and Marc Mezvinsky!
  • If it's true, it's pretty terrifying news.
  • “My mom went to cook at the White House and all I got was this tiny piece of leftover raspberry ganache."
  • from-cache

Would you like to receive updates about new stories?




















We will not share your e-mail address or other personal information.

Already subscribed? Manage your subscription.